AnxietyNCT05603000
Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
A study testing Emotion Focused Family Therapy in people with Anxiety and Depression, run by University of Guelph at 1 site in Canada.
Trial summary
Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Anxiety, Depression, Behavior Problem
- What is being tested?
- Emotion Focused Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
- Parent of child is willing to participate in intervention
- Parent is living at home with the child
Who cannot join
- Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
- Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
- Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
- Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
- Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica A Seddon, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph
Guelph, Ontario, N1G 4S7
About this study
Official title: A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly.
This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.
Read the detailed description
This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.
The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).
- Conditions
- Anxiety, Depression, Behavior Problem
- Being tested
- Emotion Focused Family Therapy
- Keywords
- children, parents, mental health, emotion, psychotherapy, parent-child relationship
- Medical subject headings
- Anxiety Disorders, Depression, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Focused Family TherapyBehavioural
Also called EFFT
The Emotion Focused Family Therapy (EFFT) intervention for this study will be delivered to groups of four to ten parents over six weekly sessions of two hours each. The goal of EFFT is to teach and empower parents to coach their child to process the emotions at the source of their mental health symptoms, to increase their child's adaptive behaviours, and to repair emotional injuries within the parent-child relationship. EFFT also targets parents' own emotional challenges that may prevent them from feeling capable or being able to support their child's treatment.
Each EFFT session will include introductions, psychoeducation about emotion and psychopathology, introduction of skills, experiential activities (e.g., chair work), open discussion and feedback, and homework activities covering the foci of EFFT: emotion coaching, behaviour coaching, therapeutic apology, and parental emotion blocks.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist (delayed intervention) | No intervention | No treatment will be administered to participants in this arm until after the 4-month follow-up in-lab assessment is completed. |
| EFFT intervention | Experimental | Treatment (6-week group Emotion Focused Family Therapy) will be administered to participants in this arm. Receives: Behavioral: Emotion Focused Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental psychopathology symptoms at 6 weeks and 4 months
This outcome will be measured through the Kessler Psychological Distress Scale (K10), a 10-item self report measure of psychological symptoms that parents will complete. Parents will rate the extent to which they are affected by various psychopathology symptoms on a five-point Likert scale from 1 (None of the time) to 5 (All of the time), with greater total scores (range = 10-50) indicating more severe psychopathology.
Measured: Change at 6 weeks; Change at 4 months
Change in child psychopathology symptoms at 6 weeks and 4 months
This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by both parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem), with greater scores (Internalizing subscale range = 0-24; Externalizing subscale range = 0-24; Total score range = 0-48) indicating more severe psychopathology.
Measured: Change at 6 weeks; Change at 4 months
Change in parental emotion regulation at 6 weeks and 4 months
This outcome will be measured through the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 36-180) indicating greater difficulties with emotion regulation.
Measured: Change at 6 weeks; Change at 4 months
Change in child emotion regulation at 6 weeks and 4 months
This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the seven Negative Emotionality items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7-28) indicating poorer emotion regulation.
Measured: Change at 6 weeks; Change at 4 months
Change in parent-child co-regulation at 6 weeks and 4 months
This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).
Measured: Change at 6 weeks; Change at 4 months
Change in parent-child relationship functioning at 6 weeks and 4 months
This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.
Measured: Change at 6 weeks; Change at 4 months
Secondary outcomes (8)
Change in parental emotion socialization at 6 weeks and 4 months
This outcome will be measured through the Coping with Children's Negative Emotions Scale (CCNES), a 12-item self-report measure of parental emotion parenting practices in response to children's expression of negative emotion. Responses are divided into six subscales representing six distinct types of parental responses. The responses will be grouped in two overall scores: Supportive (Expressive Encouragement, Problem-Focused, and Emotion-Focused Reactions) and Unsupportive (Punitive, Minimizing, and Distress Reactions) practices. Parents will rate the likelihood that they would respond in these distinct ways on a seven-point Likert scale from 1 (Very unlikely) to 7 (Very likely), with greater overall scores (range = 1-7) indicating greater levels of each type of parental response.
Measured: Change at 6 weeks; Change at 4 months
Change in parental emotion blocks at 6 weeks and 4 months
This outcome will be measured through the Caregiver Traps Scale (CTS), a 14-item self-report measure of parental emotional blocks. Parents will rate each item on a seven-point Likert scale ranging from 1 (Not likely) to 7 (Extremely Likely), with higher total scores (range = 14-98) indicating greater levels of parental emotional blocks.
Measured: Change at 6 weeks; Change at 4 months
Change in parental self-efficacy at 6 weeks and 4 months
This outcome will be measured through the Me as a Parent Questionnaire (MaaP), a 16-item self-report measure of parental self-efficacy. Parents will rate the degree to which they agree with statements about their feelings of competence in their parent role on a five-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree), with greater total scores (range = 16-80) indicating greater parental self-efficacy.
Measured: Change at 6 weeks; Change at 4 months
Fidelity of EFFT program
This outcome will be measured via audiorecording of group sessions. Fidelity scores will be calculated based on content fidelity - i.e., The degree to which providers implemented the key EFFT components, including: behaviour coaching, emotion coaching, parental emotion blocks, therapeutic apology.
Measured: Throughout intervention over 6 weeks
Change in perceived parental stress at 6 weeks and 4 months
Parents' perceived level of stress related to tasks associated with parenting will be assessed via the Parental Stress Scale. The Parental Stress Scale is an 18-item parent-report measure that assesses perceived parental stress (sample item: "Caring for my child(ren) sometimes takes more time and energy than I have to give") while taking into account positive and negative facets of parenting. The three subscales that comprise the measure (positive emotional benefits of parenting, sense of enrichment and personal fulfillment, and negative components of parenting) can be summed to form a composite score. Items are rated on a five-point Likert scale from 1 (Strongly Disagree) to 4 (Strongly Agree) with lower scores (range = 18-90) indicating lower levels of parenting stress.
Measured: Change at 6 weeks; Change at 4 months
Parental treatment satisfaction
Parental treatment satisfaction will be assessed using the parent-report of the Parent/Child Satisfaction Scales, a parent-report measure of satisfaction with child-oriented mental health services. The parent-report measure (sample item: "To what extent has our program met your child's needs?") has shown good internal consistency and test-retest reliability in prior samples of parents of clinic-referred children. Items are rated on a four-point Likert scale from 1 (Quite dissatisfied) to 4 (Very satisfied), with greater total scores (range = 8-32) indicative of higher overall treatment satisfaction.
Measured: At 6 weeks
Parent-reported change in familial functioning at 6 weeks and 4 months
Parent report of familial functioning will be assessed via the McMaster Family Assessment Device, a 60-item measure of broad family functioning that can be completed by any measure of the family system. The measure has subscales that assess particular facets of family functioning (e.g., affective responsiveness; "we cry openly"), which can be summed to form a composite score. Items are rated on a four-point Likert scale from 1 (Strongly Agree) to 4 (Strongly Disagree). Item responses are summed and divided by the number of items in the measure to compute a total score (range = 1-4), with lower total scores indicating more adaptive family functioning.
Measured: Change at 6 weeks; Change at 4 months
Change in physiological arousal at 6 weeks and 4 months
This outcome will be measured by parent and child skin conductance levels during the completion of two lab tasks together (conflict discussion and puzzle task).
Measured: Change at 6 weeks; Change at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start11 Oct 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial, consisting of an intervention arm (EFFT) and a waitlist control (delayed intervention) arm, which will occur concurrently.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristel Thomassin, University of Guelph
- Investigators
- Kristel Thomassin, Ph.D, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603000
- Sponsor's protocol ID
- EFFT
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/
PubMed 20662125Ogundele MO. Behavioural and emotional disorders in childhood: A brief overview for paediatricians. World J Clin Pediatr. 2018 Feb 8;7(1):9-26. doi: 10.5409/wjcp.v7.i1.9. eCollection 2018 Feb 8.
PubMed 29456928Campbell SB, Shaw DS, Gilliom M. Early externalizing behavior problems: toddlers and preschoolers at risk for later maladjustment. Dev Psychopathol. 2000 Summer;12(3):467-88. doi: 10.1017/s0954579400003114.
PubMed 11014748Freuchen A, Kjelsberg E, Lundervold AJ, Groholt B. Differences between children and adolescents who commit suicide and their peers: A psychological autopsy of suicide victims compared to accident victims and a community sample. Child Adolesc Psychiatry Ment Health. 2012 Jan 4;6:1. doi: 10.1186/1753-2000-6-1.
PubMed 22216948Reef J, Diamantopoulou S, van Meurs I, Verhulst FC, van der Ende J. Developmental trajectories of child to adolescent externalizing behavior and adult DSM-IV disorder: results of a 24-year longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2011 Dec;46(12):1233-41. doi: 10.1007/s00127-010-0297-9. Epub 2010 Oct 10.
PubMed 20936464Buckholdt KE, Parra GR, Jobe-Shields L. Intergenerational Transmission of Emotion Dysregulation Through Parental Invalidation of Emotions: Implications for Adolescent Internalizing and Externalizing Behaviors. J Child Fam Stud. 2014 Feb 1;23(2):324-332. doi: 10.1007/s10826-013-9768-4.
PubMed 24855329Cao M, Powers A, Cross D, Bradley B, Jovanovic T. Maternal emotion dysregulation, parenting stress, and child physiological anxiety during dark-enhanced startle. Dev Psychobiol. 2017 Dec;59(8):1021-1030. doi: 10.1002/dev.21574. Epub 2017 Oct 13.
PubMed 29027660Fabes RA, Leonard SA, Kupanoff K, Martin CL. Parental coping with children's negative emotions: relations with children's emotional and social responding. Child Dev. 2001 May-Jun;72(3):907-20. doi: 10.1111/1467-8624.00323.
PubMed 11405590Morris AS, Silk JS, Steinberg L, Myers SS, Robinson LR. The Role of the Family Context in the Development of Emotion Regulation. Soc Dev. 2007 May 1;16(2):361-388. doi: 10.1111/j.1467-9507.2007.00389.x.
PubMed 19756175Ramsden SR, Hubbard JA. Family expressiveness and parental emotion coaching: their role in children's emotion regulation and aggression. J Abnorm Child Psychol. 2002 Dec;30(6):657-67. doi: 10.1023/a:1020819915881.
PubMed 12481978Granic I, O'Hara A, Pepler D, Lewis MD. A dynamic systems analysis of parent-child changes associated with successful "real-world" interventions for aggressive children. J Abnorm Child Psychol. 2007 Oct;35(5):845-57. doi: 10.1007/s10802-007-9133-4. Epub 2007 Jun 5.
PubMed 17549621Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
PubMed 12214795Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.
PubMed 30657721Lahey BB, Applegate B, Chronis AM, Jones HA, Williams SH, Loney J, Waldman ID. Psychometric characteristics of a measure of emotional dispositions developed to test a developmental propensity model of conduct disorder. J Clin Child Adolesc Psychol. 2008 Oct;37(4):794-807. doi: 10.1080/15374410802359635.
PubMed 18991130Foroughe M, Stillar A, Goldstein L, Dolhanty J, Goodcase ET, Lafrance A. Brief Emotion Focused Family Therapy: An Intervention for Parents of Children and Adolescents with Mental Health Issues. J Marital Fam Ther. 2019 Jul;45(3):410-430. doi: 10.1111/jmft.12351. Epub 2018 Aug 13.
PubMed 30105875
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties
- ClinicalTrials.gov ID
- NCT05603000
- Acronym / sponsor ID
- EFFT
- Conditions
- Anxiety, Depression, Behavior Problem
- Keywords
- children, parents, mental health, emotion, psychotherapy, parent-child relationship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly.
This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.
Detailed description
This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.
The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial, consisting of an intervention arm (EFFT) and a waitlist control (delayed intervention) arm, which will occur concurrently.
| Arm | Type | Receives |
|---|---|---|
| Waitlist (delayed intervention) | No intervention | –No treatment will be administered to participants in this arm until after the 4-month follow-up in-lab assessment is completed. |
| EFFT intervention | Experimental | Behavioral: Emotion Focused Family TherapyTreatment (6-week group Emotion Focused Family Therapy) will be administered to participants in this arm. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
- Parent of child is willing to participate in intervention
- Parent is living at home with the child
Key exclusion criteria (5 listed)
- Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
- Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
- Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
- Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
- Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Focused Family TherapyAlso: EFFTThe Emotion Focused Family Therapy (EFFT) intervention for this study will be delivered to groups of four to ten parents over six weekly sessions of two hours each. The goal of EFFT is to teach and empower parents to coach their child to process the emotions at the source of their mental health symptoms, to increase their child's adaptive behaviours, and to repair emotional injuries within the parent-child relationship. EFFT also targets parents' own emotional challenges that may prevent them from feeling capable or being able to support their child's treatment. Each EFFT session will include introductions, psychoeducation about emotion and psychopathology, introduction of skills, experiential activities (e.g., chair work), open discussion and feedback, and homework activities covering the foci of EFFT: emotion coaching, behaviour coaching, therapeutic apology, and parental emotion blocks. | Behavioural | EFFT intervention |
Primary outcome
Change in parental psychopathology symptoms at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Kessler Psychological Distress Scale (K10), a 10-item self report measure of psychological symptoms that parents will complete. Parents will rate the extent to which they are affected by various psychopathology symptoms on a five-point Likert scale from 1 (None of the time) to 5 (All of the time), with greater total scores (range = 10-50) indicating more severe psychopathology.
Change in child psychopathology symptoms at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by both parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem), with greater scores (Internalizing subscale range = 0-24; Externalizing subscale range = 0-24; Total score range = 0-48) indicating more severe psychopathology.
Change in parental emotion regulation at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 36-180) indicating greater difficulties with emotion regulation.
Change in child emotion regulation at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the seven Negative Emotionality items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7-28) indicating poorer emotion regulation.
Change in parent-child co-regulation at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).
Change in parent-child relationship functioning at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.
8 secondary outcomes
Change in parental emotion socialization at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Change in parental emotion blocks at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Change in parental self-efficacy at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Fidelity of EFFT program
Time frame: Throughout intervention over 6 weeks
Change in perceived parental stress at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Parental treatment satisfaction
Time frame: At 6 weeks
Parent-reported change in familial functioning at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Change in physiological arousal at 6 weeks and 4 months
Time frame: Change at 6 weeks; Change at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 20662125National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/
- Background: PubMed 29456928Ogundele MO. Behavioural and emotional disorders in childhood: A brief overview for paediatricians. World J Clin Pediatr. 2018 Feb 8;7(1):9-26. doi: 10.5409/wjcp.v7.i1.9. eCollection 2018 Feb 8.
- Background: PubMed 11014748Campbell SB, Shaw DS, Gilliom M. Early externalizing behavior problems: toddlers and preschoolers at risk for later maladjustment. Dev Psychopathol. 2000 Summer;12(3):467-88. doi: 10.1017/s0954579400003114.
- Background: PubMed 22216948Freuchen A, Kjelsberg E, Lundervold AJ, Groholt B. Differences between children and adolescents who commit suicide and their peers: A psychological autopsy of suicide victims compared to accident victims and a community sample. Child Adolesc Psychiatry Ment Health. 2012 Jan 4;6:1. doi: 10.1186/1753-2000-6-1.
- Background: PubMed 20936464Reef J, Diamantopoulou S, van Meurs I, Verhulst FC, van der Ende J. Developmental trajectories of child to adolescent externalizing behavior and adult DSM-IV disorder: results of a 24-year longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2011 Dec;46(12):1233-41. doi: 10.1007/s00127-010-0297-9. Epub 2010 Oct 10.
- Background: PubMed 24855329Buckholdt KE, Parra GR, Jobe-Shields L. Intergenerational Transmission of Emotion Dysregulation Through Parental Invalidation of Emotions: Implications for Adolescent Internalizing and Externalizing Behaviors. J Child Fam Stud. 2014 Feb 1;23(2):324-332. doi: 10.1007/s10826-013-9768-4.
- Background: PubMed 29027660Cao M, Powers A, Cross D, Bradley B, Jovanovic T. Maternal emotion dysregulation, parenting stress, and child physiological anxiety during dark-enhanced startle. Dev Psychobiol. 2017 Dec;59(8):1021-1030. doi: 10.1002/dev.21574. Epub 2017 Oct 13.
- Background: PubMed 11405590Fabes RA, Leonard SA, Kupanoff K, Martin CL. Parental coping with children's negative emotions: relations with children's emotional and social responding. Child Dev. 2001 May-Jun;72(3):907-20. doi: 10.1111/1467-8624.00323.
- Background: PubMed 19756175Morris AS, Silk JS, Steinberg L, Myers SS, Robinson LR. The Role of the Family Context in the Development of Emotion Regulation. Soc Dev. 2007 May 1;16(2):361-388. doi: 10.1111/j.1467-9507.2007.00389.x.
- Background: PubMed 12481978Ramsden SR, Hubbard JA. Family expressiveness and parental emotion coaching: their role in children's emotion regulation and aggression. J Abnorm Child Psychol. 2002 Dec;30(6):657-67. doi: 10.1023/a:1020819915881.
- Background: PubMed 17549621Granic I, O'Hara A, Pepler D, Lewis MD. A dynamic systems analysis of parent-child changes associated with successful "real-world" interventions for aggressive children. J Abnorm Child Psychol. 2007 Oct;35(5):845-57. doi: 10.1007/s10802-007-9133-4. Epub 2007 Jun 5.
- Background: PubMed 12214795Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
- Individual participant dataSharing planned: No
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica A Seddon, MSc contact
Kristel Thomassin, Ph.D principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Focused Family Therapy in people with Anxiety and Depression, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristel Thomassin, Ph.D (519-824-4120 ext. 3016, kristel.thomassin@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parental psychopathology symptoms at 6 weeks and 4 months (time frame: Change at 6 weeks; Change at 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603000, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.